A number of recent studies have identified a much stronger link between the type 2 diabetes drug Actos and bladder cancer than was indicated during pre-approval clinical trials. In June of 2011, the FDA issued a warning stating that based on dose and duration of use, Actos users face a 40% increased risk of developing bladder cancer compared to patients who do not take the drug. Actos is manufactured by Takeda Pharmaceuticals, and has been on the U.S. market since 1999.
Free Actos Bladder Cancer Lawsuit Evaluation: If you or a loved one developed bladder cancer after taking Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Actos and we can help.
Studies Link Actos to Bladder Cancer
Three recent medical studies are most often cited regarding the risk Actos users face of developing bladder cancer. The first is a decade-long study performed by Kaiser Permanente. Sponsored by Takeda Pharmaceuticals, the research began in 2002 after pre-approval clinical trials found an increase in bladder tumors in laboratory rats. Although the final results have yet to be released, a 5-year interim analysis identified a 40% increased risk of bladder cancer in type 2 diabetics who used Actos for over one year. These findings were the basis of the FDA’s 2011 label and insert updates regarding Actos bladder cancer.
Unlike previous warnings, the 2011 update was added to the Warnings and Precautions section, and not to the Contraindications section. However, there was not an update to the Actos’ black-box label indicating the increased risk of bladder cancer.
The most widely cited study regarding the Actos bladder cancer link was a 3-year study conducted between 2006 and 2009 that looked at some 1.5 million patients. Researchers identified a statistically significant indication that pioglitazone users face an increased risk of developing bladder cancer. The study’s authors stated that their findings were very similar to those of the Kaiser Permanente study.
In June of 2011, Actos was banned in France. Germany quickly followed suit, except that it limited suspension to all new cases. Two months later, Takeda Pharmaceuticals formally pulled Actos off those markets. In April 2011, the American Diabetes Association issued a report that reviewed adverse drug reactions filed with the U.S. Food & Drug Administration. The researchers indicated that they “found a definite signal for bladder cancer associated with pioglitazone use.”
One of the most recent studies to research the Actos bladder cancer link was published in the May 2012 issue of the British Medical Journal (BMJ). The study involved 115,727 test subjects, and found that Actos use increased the risk of bladder cancer by 83%. The study also revealed that the bladder cancer risk increases with long-term use of Actos.
How Can Actos Cause Bladder Cancer?
Among the known risk factors for bladder cancer are old age, chronic bladder infections, and treatment with Actos. Researchers have stated that because the leading cause of bladder cancer is cigarette smoking, it is one of the most preventable forms of cancer. Studies indicate that smoking raises the risk for bladder cancer by approximately 4-fold.
Although the precise mechanisms by which Actos causes bladder cancer are still not clearly understood, the leading medical theory is that the disease is caused by an increased concentration of toxic chemicals in the urine. Over time, prolonged exposure by the bladder to these chemicals causes cancer. Bladder cancer has been described as a signature complication of Actos, pointing to the theory of toxic exposure being the primary cause of the disease.
Do I Have an Actos Bladder Cancer Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos Lawsuits. We are handling individual litigation nationwide and currently accepting new Actos bladder cancer cases in all 50 states.
Free Actos Bladder Cancer Lawsuit Evaluation: If you or a loved one developed bladder cancer after taking Actos, you should contact our law firm immediately. You may be entitled to compensation by filing an Actos Suit and we can help.